Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06976177

Study of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis

Led by Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Updated on 2025-05-16

310

Participants Needed

1

Research Sites

79 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a multi-center, open, single-arm phase IIb clinical study comprising 2 parts, which Part A will enroll about 110 subjects, and Part B will enroll about 190 subjects to investigate long-term efficacy and safety of MT1013 after treatment.The treatment duration for Part A MAD study is 52 weeks and the duration for Part B study is 26 weeks.

CONDITIONS

Official Title

Study of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subject capable of understanding written information, willing to participate, and able to provide written informed consent
  • Male or female subjects at least 18 years old when signing the informed consent
  • Undergoing maintenance hemodialysis three times a week or five times every two weeks for at least three months
  • Dialysate calcium concentration of at least 1.25 mmol/L (2.5 mEq/L)
  • Diagnosed with Secondary Hyperparathyroidism (SHPT)
Not Eligible

You will not qualify if you...

  • Primary hyperparathyroidism
  • Refusal to stop taking cinacalcet, etelcalcetide, or other calcimimetics during the study
  • Use of RANKL inhibitors such as denosumab within 6 months before screening
  • Diagnosis of gastrointestinal bleeding within 6 months prior to screening
  • Severe uncontrolled hypertension (systolic >180 mmHg and/or diastolic >110 mmHg) despite optimal treatment before enrollment
  • Parathyroidectomy within 6 months prior to screening or planned during the study
  • Allergy or intolerance to any component of the investigational drug
  • History of epileptic seizures or ongoing epilepsy treatment within 1 year prior to screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

First Affiliated Hospital College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

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Research Team

J

Jiang hua Chen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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